AgeX Therapeutics(US:AGE)2023-03-30 16:00Part I Business AgeX Therapeutics develops therapeutics for human aging and degenerative diseases, leveraging core technologies like PureStem® and pursuing corporate restructuring - The company aims to develop and commercialize novel therapeutics for human aging and degenerative diseases, leveraging expertise in cellular immortality and regenerative biology47 - Core technology platforms include PureStem® for cell therapies, UniverCyte™ for hypoimmunogenic cells, HyStem® for cell delivery, and iTR for reversing cellular aging487679 - Key discovery-stage product candidates include AGEX-BAT1 for metabolic disorders, AGEX-VASC1 for ischemic diseases, and AGEX-iTR1547/1550 for scarless tissue regeneration7172 - Due to limited financial resources, AgeX eliminated in-house R&D, shifting to outsourcing, licensing, and sponsored research agreements1484239 - The company is pursuing significant corporate restructuring, including a potential merger with Serina Therapeutics and a spinoff of its iTR-focused subsidiary, Reverse Bioengineering Inc115961 Risk Factors The company faces substantial risks, including a 'going concern' warning, heavy reliance on Juvenescence, and significant operational and regulatory challenges - Financial Condition: The company has a history of operating losses, an accumulated deficit of $116.2 million as of year-end 2022, and its ability to continue as a 'going concern' is in substantial doubt, highly dependent on additional financing, primarily from Juvenescence6203207 - Relationship with Juvenescence: Juvenescence owns a significant percentage of common stock, is a major creditor, and can substantially influence corporate matters, creating potential conflicts of interest and potentially making AgeX a 'controlled company' if loans are converted9222225 - Planned Restructuring: Significant uncertainties and risks are associated with the potential merger with Serina Therapeutics and the planned spinoff of the Reverse Bio subsidiary, with no assurance of consummation and potential dilution to existing stockholders11227236 - Business Operations: AgeX has reduced staffing, eliminated research labs, and has no in-house R&D capabilities, with no product candidates tested in clinical trials and preclinical success not indicative of future results14239242 - Industry and Regulatory Risks: The company faces significant competition from better-funded companies, a lengthy, costly, and unpredictable FDA approval process, especially for novel cell and gene therapies, and potential restrictive regulations due to ethical and social concerns about stem cell use20297300 - Dependence on Third Parties: AgeX is dependent on future collaborations for product development, clinical trials, manufacturing, and commercialization, lacking internal resources for these activities27372382 Unresolved Staff Comments The company reports that it has no unresolved staff comments - Not Applicable428 Properties The company leases a small office space of 101 square feet in Alameda, California, with a monthly rent of $844 - The company's principal office is a 101 square foot leased space in Alameda, CA, with the lease beginning January 1, 2023, at a monthly rent of $844429 Legal Proceedings The company is not currently involved in any material litigation or legal proceedings - The company is not presently involved in any material litigation or proceedings430 Mine Safety Disclosures This item is not applicable to the company - Not applicable430 Part II Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities AgeX common stock trades on NYSE American, with details on record holders and equity compensation plan information - The company's common stock has traded on the NYSE American under the symbol "AGE" since November 29, 2018431 - As of March 20, 2023, there were 232 holders of record of the common stock431 Equity Compensation Plan Information as of December 31, 2022 | Plan Category | Number of Shares to be Issued upon Exercise (thousands) | Weighted Average Exercise Price | Number of Shares Remaining Available for Future Issuance (thousands) | | :--- | :--- | :--- | :--- | | AgeX Stock Option Plans Approved by Stockholders | 3,264 | $2.25 | 5,139 | Management's Discussion and Analysis of Financial Condition and Results of Operations Management expresses substantial doubt about the company's going concern ability due to significant losses and negative cash flows - The company has incurred significant operating losses since inception, with an accumulated deficit of $116.2 million as of December 31, 2022, and management expects losses to continue437 - A going concern assessment raises substantial doubt about the company's ability to operate for at least one year from the report's issuance date, given its current cash and available financing441496 Comparison of Results of Operations (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $34 | $144 | ($110) | -76.4% | | Research and development | $1,025 | $1,456 | ($431) | -29.6% | | General and administrative | $5,971 | $6,708 | ($737) | -11.0% | | Total operating expenses | $6,996 | $8,164 | ($1,168) | -14.3% | | Net Loss from Continuing Operations | ($10,522) | ($8,582) | ($1,940) | 22.6% | - The decrease in revenue was primarily due to the completion of an NIH grant in 2021, while the decrease in operating expenses reflects reduced scientific consulting, outside research, and compensation costs following 2020 staff reductions482486487 Summary of Cash Flows (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($5,939) | ($7,765) | | Net cash provided by investing activities | $0 | $716 | | Net cash provided by financing activities | $6,000 | $7,496 | Financial Statements and Supplementary Data Audited financial statements show significant losses and accumulated deficit, with the auditor expressing substantial doubt about going concern - The auditor's report contains a paragraph highlighting substantial doubt about the Company's ability to continue as a going concern due to recurring losses, negative cash flows, and insufficient cash to fund operations for the next twelve months510 Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $645 | $584 | | Total Assets | $3,241 | $3,154 | | Total Liabilities | $20,556 | $15,029 | | Accumulated Deficit | ($116,210) | ($105,748) | | Total Stockholders' Deficit | ($17,315) | ($11,875) | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | Total Revenues | $34 | $144 | | Total Operating Expenses | $6,996 | $8,164 | | Net Loss | ($10,522) | ($8,685) | | Net Loss Per Share | ($0.28) | ($0.23) | - As of December 31, 2022, the company had federal net operating loss carryforwards of approximately $52.8 million and state NOLs of $14.9 million, which are subject to a full valuation allowance491492683 - The company received a deficiency letter from the NYSE American in November 2021 for failing to meet continued listing standards, but submitted a compliance plan and was granted an extension until May 17, 2023, to regain compliance704 - Subsequent to year-end, in early 2023, the company amended its secured note with Juvenescence to borrow up to an additional $2.0 million, extended the maturity of its 2020 loan, and entered into a new $10 million secured note with Juvenescence to fund a loan to Serina Therapeutics in contemplation of a potential merger706710 Controls and Procedures Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2022 - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2022726 - Management assessed internal control over financial reporting as effective as of December 31, 2022, based on the 2013 COSO framework729 Part III Directors, Executive Officers, and Corporate Governance The report details the Board of Directors and executive officers, highlighting the close ties and influence of major shareholder Juvenescence - The Board of Directors as of March 20, 2023, includes Gregory H. Bailey, M.D., Joanne M. Hackett, Ph.D., and Michael H. May, Ph.D730 - Key executive officers include Michael D. West, Ph.D. (CEO), Andrea E. Park (CFO), and Nafees N. Malik (COO), with Dr. Bailey as Executive Chairman of Juvenescence and Dr. Malik as a Juvenescence employee, highlighting close ties730736738 - The company has an Audit Committee chaired by Michael H. May, who is considered an "audit committee financial expert"734 - The company has adopted a Code of Business Conduct and Ethics applicable to all officers and directors735 Executive Compensation Executive compensation for 2022 is detailed, including CEO, CFO, and COO salaries, with no stock or option awards granted 2022 Summary Compensation Table | Name and Principal Position | Year | Salary ($) | Option Awards ($) | All Other Compensation ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | | Michael D. West, CEO | 2022 | 546,782 | 0 | 15,250 | 562,032 | | Andrea E. Park, CFO | 2022 | 281,228 | 0 | 14,061 | 295,289 | | Nafees N. Malik, COO | 2022 | 282,272 (1) | 0 | 0 | 282,272 | - Note (1): Dr. Malik's compensation represents consulting fees paid to Juvenescence for his services746747 - Employment agreements for the CEO and CFO provide for severance benefits, including salary continuation and accelerated vesting of equity awards, if terminated without "cause" or if they resign for "good reason," with enhanced benefits following a "Change of Control"755756 - The company's 2017 Equity Incentive Plan allows for the granting of stock options, restricted stock, SARs, and RSUs, with 5,139,000 shares remaining available for grant as of December 31, 2022659672 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Juvenescence Limited and its affiliates are the largest beneficial owner, holding approximately 78.7% of the company's common stock Security Ownership of Major Holders (as of March 20, 2023) | Name of Beneficial Owner | Number of Shares Beneficially Owned | Percentage of Shares Beneficially Owned | | :--- | :--- | :--- | | Juvenescence Limited and certain affiliates | 79,425,155 | 78.7% | | Broadwood Partners, L.P. and certain affiliates | 3,003,446 | 7.9% | | All executive officers and directors as a group (7 persons) | 2,512,436 | 6.2% | - Juvenescence's beneficial ownership includes 16,447,500 shares held directly, 13,271,230 shares issuable via warrants, and 49,706,335 shares issuable upon conversion of outstanding debt795 Certain Relationships and Related Transactions, and Director Independence The company has extensive financial relationships with Juvenescence, its largest shareholder, including multiple secured loan agreements - AgeX is heavily reliant on financing from its largest shareholder, Juvenescence, through several loan agreements, with total borrowings from Juvenescence at $32,160,000 as of March 20, 2023210497 - Key loan facilities include the $8.0 million 2020 Loan Agreement, the $15.16 million 2022 Secured Note (of which $14.16 million was drawn as of March 20, 2023), and a new $10 million Secured Note executed in March 2023625629815 - The loans from Juvenescence are secured by a lien on substantially all of AgeX's assets, including its intellectual property and shares in subsidiaries, with default potentially leading to foreclosure and loss of all assets638821 - In connection with the loans, AgeX has issued and will issue a substantial number of common stock purchase warrants to Juvenescence, further increasing Juvenescence's potential ownership stake627812 - In March 2023, AgeX used proceeds from the $10 million Secured Note from Juvenescence to lend $10 million to Serina Therapeutics, in contemplation of a potential merger between AgeX and Serina815717 - Three directors are deemed independent (Hackett, May, Bailey), but Dr. Bailey's independence is noted as not meeting Audit Committee standards under Rule 10A-3 due to his role as Executive Chairman of Juvenescence827828 Principal Accounting Fees and Services Total fees paid to independent accounting firms were $411,000 in 2022 and $357,000 in 2021, with all services pre-approved Accountant Fees (in thousands) | Fee Category | 2022 | 2021 | | :--- | :--- | :--- | | Audit Fees | $358 | $303 | | Audit-Related Fees | $53 | $54 | | Total Fees | $411 | $357 | - 100% of the fees paid to the auditors in 2022 and 2021 were pre-approved by the Audit Committee832 Part IV Exhibits and Financial Statement Schedules This section lists financial statements, schedules, and exhibits, including loan agreements with Juvenescence and unaudited financials for Reverse Bioengineering Inc - The filing includes a list of exhibits, such as the Asset Purchase Agreement with Escape Therapeutics, various loan and warrant agreements with Juvenescence, and the company's 2017 Equity Incentive Plan835 - Unaudited financial statements are provided for the subsidiary Reverse Bioengineering, Inc., whose securities are pledged as collateral for debt owed to Juvenescence844 Reverse Bioengineering, Inc. Financial Highlights (Unaudited, in thousands) | | 2022 | 2021 | | :--- | :--- | :--- | | Balance Sheet | | | | Total Liabilities | $936 | $388 | | Total Stockholders' Deficit | ($936) | ($388) | | Statement of Operations | | | | Net Loss | ($548) | ($262) | Form 10-K Summary The company states there is no Form 10-K summary provided - None849